Hep C Drug Deal Seen as Helpful to Patients

Patients will have access to Viekira Pak at all stages of the disease.

Express Scripts' recent decision to cover AbbVie's Viekira Pak treatment for hepatitis C genotype 1 -- to the exclusion of Gilead's ledipasvir/sofosbuvir combo (Harvoni) and Janssen Therapeutics' simeprevir (Olysio) -- should be seen as good news for doctors and patients, according to one hepatologist.

Critics of the decision have pointed out that Viekira Pak needs to be taken three times a day compared with once-daily Harvoni. But Reau, an associate professor of medicine at the University of Chicago, noted that Express Scripts, a pharmacy benefit management (PBM) firm, has agreed to provide the medication regardless of what stage of hepatitis C the patient is in.

"If you are trying to treat a patient who doesn't have fibrosis, a lot of insurers aren't approving [Harvoni] because it's so expensive," said Nancy Reau, MD, of the University of Chicago, who is on the joint hepatitis guideline panel for the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases (IDSA/AASLD), but was speaking only for herself.

"Your option for the patient that did not have advanced fibrosis was often no treatment, but now you have a treatment -- and not only a treatment but a highly effective treatment. If I can get my patients cured, that's a positive thing."

Reau noted that Express Scripts' announcement, which takes effect Jan. 1, came shortly after both the FDA approval of Viekira Pak on Friday and the release of a guideline update from IDSA/AASLD soon after. "In the [guideline] document, both Viekira Park and Harvoni are on equal footing," she pointed out. "That's probably a reflection of the fact that the efficacy is the same with both regimens. Yes, taking three pills a day is slightly less convenient, but it's not less safe and not less efficacious."

She noted that some media reports suggested that nearly half of the patients prescribed Harvoni might do just as well on only 8 weeks of treatment, "but the guidance documents don't recommend 8 weeks -- there's only a footnote to consider [such a regimen] if the patient has a low viral load. The consensus from the expert panel is ... that 12 weeks is better."

Both treatments are expensive; Sovaldi (sofosbuvir), Gilead's single-drug treatment -- of which Harvoni is the next-generation version -- is priced at $84,000, or $1,000 per pill for a 12-week treatment, while Viekira Pak (a combination of ombitasvir, dasabuvir, paritaprevir, and ritonavir) is priced similarly, at a list price of $83,319. However, Express Scripts was able to work out an arrangement to get Viekira Pak for a discounted price -- estimated to be around $51,000-$66,000 -- which appeared to be part of the impetus for the arrangement.

"For the first time, a pharmaceutical manufacturer and a pharmacy benefit manager have created an agreement to deliver on the promise of a curative therapy for hepatitis C patients," Steve Miller, MD, senior vice president and chief medical officer of Express Scripts, said in a statement issued Monday. "Pharmaceutical innovation must be rewarded based on the value it brings to patients and payers. This agreement marks a fundamental change in how sustainable access and affordability will be delivered to hepatitis C patients."

The Express Scripts policy does allow a few exceptions. For instance, Sovaldi, Harvoni and Olysio will continue to be available for patients who have already begun treatment regimens. Sovaldi also will be available for patients with other hepatitis C genotypes who have advanced liver disease, the company said.

But some physicians are not entirely happy with the new policy even with those exceptions. "There are some patients for whom one drug regimen is more suited than another," said David Thomas, MD, MPH, director of the division of infectious diseases at Johns Hopkins University and co-chair of the IDSA/AASLD guideline panel, in an email to MedPage Today.

"Chiefly that has to do with interactions between the new [hepatitis C virus] medications and the patient's existing medicines. In those instances, having more than one choice could be beneficial."

Wall Street analysts are also a little uncertain of what the Express Scripts deal will mean for Gilead, which had been making nearly $3 billion per quarter in revenue from Sovaldi. "The idea that discounting is taking place behind the scenes is not at all surprising (and something that we were modeling for), but the fact that it is significant enough to perpetuate a multi-year exclusive contract (with less restrictions on which patients can be treated) is extremely surprising," wrote Cory Kasimov, a biotechnology analyst at JP Morgan in New York City, in a note on the subject Tuesday.

"The extent of the damage is [to be determined], as we suspect other payers/PBMs are lining up to follow [Express Scripts'] lead. Regardless, this morning's news is a double whammy, as it likely means lower share for [Gilead] and accelerated/more significant price erosion than we had previously been expecting."

Kasimov added that "Every doc we have spoken to preferred Harvoni over [AbbVie's] regimen based on more convenient 1-pill ... dosing and lack of ritonavir boosting ... Further, many docs indicated that they would likely use the 8-week regimen where possible, which is significantly cheaper on a gross basis ... Thus, we do expect docs (and patients) will push back on this restriction, but with questionable impact."

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